Thursday, September 22, 2016

Fixing the supplement market for consumers

Unsubstantiated claims could be on their way out in Canada

When it comes to regulating and selling dietary supplements, should consumer interests be higher priority than those of manufacturers? While regulations are seemingly created to protect consumers, governments around the world have consistently given manufacturers the upper hand, prioritizing a company’s desire to sell a product over a consumer’s right to a marketplace with safe, effective products. Nowhere is this more the case than in Canada and the United States, where similar regulatory approaches have led to an industry boom and massive sales, but also a confusing marketplace for consumers and no persuasive evidence that all those supplements have any meaningful effects on our health. Drug store shelves in 2016 are packed with hundreds of products with unsubstantiated claims and untested products, and little credible information to guide selection. Since its beginnings, the contributors to this blog has been consistent in calling for more appropriate regulation: one that puts consumers first, not manufacturers, and evaluates all products (drugs, supplements or otherwise) with a consistent standard of science and evidence. Today, it looks like one regulator is preparing to move in that direction. Health Canada, Canada’s equivalent to the FDA, has proposed a new regulatory approach that is expected to block manufacturers from selling products with unsubstantiated and often misleading health claims. And they are asking for your input. Carly Weeks in the Globe and Mail writes,

Currently, natural health products are regulated in a manner similar to drugs – manufacturers must apply to Health Canada for a licence to sell and products are assigned a unique number that must appear on product labels to signal the department’s approval. But unlike drugs makers, natural health product manufacturers are not required to provide robust evidence that a product works before it’s allowed on the market.

Under the proposed new system Health Canada would bring natural health products, over-the-counter drugs and cosmetics under one set of rules and regulate them based on the potential health risks they pose.

The new regime would classify many vitamin, mineral and homeopathic products and cosmetics as “low risk,” meaning they would not be licensed by Health Canada. Manufacturers would still have to meet Health Canada’s quality standards, but they would be prohibited from making disease treatment or prevention claims on product labels. Any other claims on product labels would have to be accompanied by a disclaimer stating the information has not been verified by Health Canada.

Products deemed “moderate” or “higher” risk – such as over-the-counter painkillers, allergy medications and products that contain new medicinal ingredients – would be reviewed by Health Canada and could only make health claims if enough scientific evidence is presented to prove the statements.

Treating products according to their risk, rather than their source, has the potential to be far more sensible from a scientific perspective than the status quo we see in Canada and around the world.

Why Canada Lowered the Evidence Bar

Not too long ago, there was no such thing as a “natural health product” in Canada. Products were either drugs, and were registered as such, or they were food products, and drug regulatory requirements did not apply. A grey area existed and and all kinds of supplements appeared – with no specific regulatory oversight, no defined quality or content standards, and no objective evaluation of the efficacy claims. In 2004, the Natural Health Product Regulations (NHPR) became a reality. They grouped together a disparate group of products: nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy. Rather than fully regulating these products as drugs, or leaving them unregulated, the NHPR were a regulatory compromise. They introduced manufacturing quality, safety, labelling, importation, and distribution standards, while dramatically relaxing the standards for product efficacy claims. For example Health Canada’s Evidence for Homeopathic Medicines: Guidance Document (yes, it’s an actual document) states that applications for licenses for homeopathic products must include “evidence” to support the “safety, efficacy, and quality” of a homeopathic medication. Health Canada realized that given there’s no credible evidence to support homeopathy, it had to lower the evidence bar. So to Health Canada, anecdotes became evidence. Homeopathic manufacturers can use materia medica, which are essentially compilations of anecdotal information, to satisfy this requirement. Health Canada offers a list of 59 references it will accept, including texts that date back to 1834, which was three decades before germ theory was proposed. This is acceptable “evidence” today to earn Health Canada’s seal of approval.

Is there anything Health Canada won’t approve?

Health Canada’s absurdly low evidence standard was elegantly demonstrated by the television show CBC Marketplace in 2015. Having having previously described how homeopathic remedies lack any medicine at all, they went one further, and decided to test Health Canada’s own licensing process. They applied for approval to market a homeopathic remedy they named “Nighton” (an anagram of “nothing”) to be used to treat fever and pain in infants and children. For evidence, they submitted a few pages photocopied from an old homeopathy textbook. No trials were conducted and no safety data was provided. Just some forms, a few photocopies and a fee. Without any questions, their product was approved and licensed as a “natural health product”, and for a time, was listed in the national database of health products Health Canada declared were “safe, effective, and of high quality.”

Industry wins, and consumers lose

After being embarrassed by the CBC, Health Canada finally acted. It announced new rules for homeopathic remedies marketed as cough, cold and influenza remedies (but ignoring the thousands of other homeopathic products had approved.) It prohibited any products for children 12 and under, unless those claims are supported by scientific evidence. That’s a significant change, and essentially created an impossible bar for homeopathy manufacturers.

Health Canada took action again when it was demonstrated (again by CBC Marketplace) that Canadian homeopaths were selling homeopathic “nosodes” as vaccine substitutes. A “nosode” is a remedy that starts with infectious material, like polio, measles or smallpox, and then it’s diluted sequentially until mathematically, there’s nothing left but water. Health Canada had approved 82 of these “nosodes” for sale over the years, and naturopaths and homeopaths were selling them as vaccine substitutes that were claimed to be “Health Canada approved”, which was technically true – but approval as a “natural health product” means completely different standards than actual medicine. It should be self-evident that fake vaccines are a public health problem. Canadian advocacy group Bad Science Watch launched a public campaign against nosodes, and succeeded in getting Health Canada’s agreement to force commercial manufacturers to place a label on their products stating “This product is not intended to be an alternative to vaccination.”

Putting warning labels on approved products to tell consumers that they really don’t actually work is a clumsy and possibly dangerous approach to regulation, and sidesteps the real issue: shaping a marketplace where consumers have good information to make their own self-care decisions. The picture below is from a retail pharmacy near me, where you can see homeopathic remedies shelved alongside real drug products for treating colds. All are approved for sale, but they are held to widely different regulatory standards – something that few consumers (and possibly even health professionals) understand:

Some of these products contain no medicine at all.

Why the change?

When shopping for a self-care product, you will often see various options grouped together on store shelves based on the condition for which they are intended to be used. For example, a wide variety of products for skin care may be grouped together or a number of different products for headache relief may sit next to each other on the shelf. Many of the products you see might make the same or similar claims about what they do and they may have packaging that all looks alike. These similarities may lead a consumer to believe that these products are equally effective and have had to follow the same rules and oversight to be allowed to be sold, but this may not be the case.

Based on definitions in legislation and regulations, Health Canada considers self-care products to be made up of three different product types:

Cosmetics, which are used for cleaning, improving or altering the complexion, skin, hair or teeth, such as moisturizing creams, deodorants, and shampoos;

Non-prescription drugs, also commonly referred to as “over-the-counter drugs” which include products for pain relief, cold and flu symptoms, and allergy relief.

Health Canada has different ways of overseeing the safety, efficacy, and quality of cosmetics, natural health products, and non-prescription drugs. By safety, we mean that the product will not be harmful or toxic when you use it according to the directions and warnings on the label. Efficacy refers to what the product is meant to do and is usually represented by a claim, e.g., “relieves headache”. A health claim is a description on the product about what it does in relation to someone’s health. Finally, quality means that the product is manufactured under controlled conditions and will be made properly.

And in this section, Health Canada finally acknowledges that homeopathy is magical thinking:

The level of evidence required for similar claims varies. Generally speaking, non-prescription drug claims require supporting scientific evidence. For natural health products, however, a wider range of supporting information is accepted for claims, ranging from scientific evidence to encyclopedias of health and wellness philosophies based on premises other than science. Health Canada’s practice of accepting other non-scientific information to support claims for natural health products is based on an attempt to recognize that these products are not the same as conventional drugs, and often have a basis in philosophies that support the general health benefits of some ingredients through means other than scientific standards. Some products, like traditional Chinese medicines, are based on thousands of years of use. Homeopathic products (also a type of natural health product) are grounded in homeopathy, a system that is not supported by science.

What this means for consumers is that a non-prescription drug and a homeopathic product could be making a similar claim (such as “relieves cough”) but only the claim on the non-prescription drug would be supported by scientific evidence. In our current system, this difference may not be clear to the consumer because there is no signal on the product label, so these products could appear to consumers as if they are equally effective.

This is exactly the situation we are in today. Products need proper labelling to ensure that consumers have the information they need to make evidence-informed health decisions. When consumers buy homeopathy thinking that they’re buying medicine, they’re wasting time and money, and may be putting their own health at risk.

What Health Canada wants to hear

Products of similar risk profiles would be treated in a similar manner: This ensure rules for bringing products to market are more consistent and easier to understand

The Department would review health claims based on a new definition. Companies would require scientific proof to support these health claims.

A risk-based approach to compliance and safety monitoring will continue. This allows Health Canada to take quick action to protect consumers

I really like the wording in this section of the consultation summary, and I wonder if someone’s been reading this blog in Ottawa:

Health Canada, as a science-based regulator, wants to make sure that Canadians can trust that a standard has been met when we authorize a claim. We want to support consumers in making informed choices in selecting and using self-care products by providing them with the necessary information to do so. This means a proposal that redefines what is currently considered a health claim and requiring scientific evidence to support these health claims. Under this proposal, only those claims that pertain to diagnosis, treatment, prevention, cure, or mitigation of a disease or serious health condition will be reviewed by Health Canada.

What this means is that non-medicine, like homeopathy, would no longer be reviewed and approved by Health Canada. And the manufacturer wouldn’t be permitted to make efficacy or treatment claims, as a result. Any claims would have to be supported by evidence, and held to the same standards as drug products. What Health Canada seems to prefer are more similar to the structure/function claims that you see in the United States. Examples of wording they would find acceptable would include:

Improves the look of acne scars

Moisturizes and nourishes the skin

Cleans teeth

Product A is 50% more effective than Product B

“Number one choice of dentists”

Source of omega-3

Generally supports health maintenance

Helps metabolize fat

Maintains healthy bones

Source of vitamin C

It’s this particular part of the proposal that I have the most problem with. Many of these statements are meaningless to consumers and health professionals alike. “Source of vitamin C” or “moisturizes the skin” is fair, but what does it mean that a product supports “health maintenance”? And how could a regulator approve a relative effectiveness claim, unless there’s actual evidence of efficacy to begin with? These types of claims need strict limits, otherwise Canada risks creating an American-style supplement market, where anything still goes.

The supplement industry hates the proposal: A good sign?

The supplement industry in Canada, represented by the Canadian Health Food Association, has launched a “NHPs are not drugs!” campaign. They’re ignoring the fact that this move is about labelling and information, not access, and they’re fighting to keep the lowered bar for efficacy claims. They’re intent on keeping the marketplace healthy – for manufacturers:

Our current pre-market approval system respects traditional values from many different cultures and allows Canadians freedom of choice and access to these important products. Changing the current NHP Regulations is trying to fix a system that is not broken. Natural health products shouldn’t be regulated like drugs. Natural health products are different in nature from drugs and must be treated differently.

They’re asking supporters to send the following letter to their Member of Parliament. Fill out your address and this letter will be auto-generated:

Dear XXXX:

As a constituent in your riding I was shocked to learn of a proposal from bureaucrats at Health Canada to take away consumer choice in natural health products. Our natural health products are just that – natural! They are not drugs and shouldn’t be regulated the same way as drugs.

Natural health products are safe and effective, and the current regulatory framework protects consumers and consumer choice. The proposal by bureaucrats throws out a world-class Canadian system brought in by Liberal Health Minister Allan Rock with all party support and a full year of parliamentary committee study.

As someone from your community, I am asking that you oppose this proposal and make my views known to the Minister of Health.